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The limited supply of this common reagent is set to drive drug prices higher, but there are ways for companies to lessen the impact.
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The current state of political affairs in the U.S. does not bode well for the direction of that turn. The country is at real risk of losing its long-held lead in biotech innovation.
The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is part of a larger communications crisis unfolding at the agency over the past nine months that has also ensnarled Sarepta, Capricor, uniQure and many more.
The rare disease drugmaker is facing potential competitors for achondroplasia drug Voxzogo. Is a big M&A deal with two approved assets enough to maintain investor interest?
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The FDA issued a rare Refusal-to-File letter to Moderna over its mRNA-based influenza vaccine application, in an unusual move that sent the biotech’s shares tumbling.
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The agency’s warning letter outlines Applied Therapeutics’ failure to provide adequate information regarding the clinical trial—including a dosing error for govorestat—claims that the company said it had already addressed.
Amylin analogs present a strong alternative or complement to GLP-1 receptor agonists, potentially eliciting higher-quality weight loss with a cleaner tolerability profile.
Novartis, Gilead, Roche and Takeda commit to new partners in a spate of mid-sized collaborations this week. Meanwhile, Applied Therapeutics’ stock tanks 80% after govorestat is denied approval, Intra-Cellular Therapies seeks to expand Caplyta into major depressive disorder and the FDA investigates the safety of bluebird bio’s Skysona.
Not exactly known for its dealmaking, Sarepta Therapeutics has thrown down a massive wad of cash to work with Arrowhead Pharmaceuticals on RNAi-based medicines.
Intra-Cellular submitted its application to the FDA for Caplyta’s approval in major depressive disorder, potentially opening up an additional $1 billion in sales. Still, the stock remains “cheap,” according to Jefferies analysts.
Keros’ elritercept has shown promising efficacy signals in myelofibrosis and myelodysplastic syndromes and could pose a formidable challenge to Bristol Myers Squibb’s Reblozyl.
The collaboration will see COUR and Roche’s Genentech leverage the biotech’s antigen-specific immune tolerance platform to develop and commercialize therapies for an undisclosed autoimmune disease.
The deal with Tubulis will help Gilead regain its footing in the ADC space following the withdrawal of Trodelvy in bladder cancer and its late-stage fail in NSCLC.
At Drexel University’s Graduate School of Biomedical Sciences and Professional Studies, graduate students and active professionals can take interdisciplinary, career-oriented programs designed to help launch their careers and take them to the next level.
Alongside the layoffs, Alligator will also suspend work on all of its earlier-stage assets and devote its resources to lead candidate mitazalimab, being developed for the frontline treatment of metastatic pancreatic cancer.